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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

If you had any doubt that clinical trial transparency is shaping up to be one of the hottest regulatory topics, look no further than the European Medicines Agency (EMA), which announced this week that it had received more than 1,000 comments on its draft transparency policy.

Background

In recent years, a growing number of voices have been clamoring for greater transparency of clinical trials results, especially after some companies were found to have hidden unfavorable data regarding the safety of drugs which were later recalled.

In the US, these efforts have seen limited success thanks to legislation passed to require basic trials data to be published to ClinicalTrials.gov. However, top-line results of many trials are not contained within that database, and many are never made public.

But in the EU, the European Medicines Agency (EMA) is now forging ahead with an ambitious new proposal that would require much more in-depth clinical trials reporting for all trials, regardless of the drug's eventual approval status.

EMA has been moving toward a&nbsp;policy of transparency&nbsp;since at least November 2010, when it first announced its intent to eventually publish all research data provided to it in support of a regulatory dossier or application. The plan kicked into high gear in July 2012, when reports emerged that EMA was formally developing the plan, which it did in June 2013.

That plan has won rave reviews from some transparency advocates, including those behind the&nbsp;AllTrials&nbsp;campaign, which is campaigning for the release of all clinical data. Industry, however, has been far less supportive, with at least two-AbbVie (formerly of Abbott Laboratories) and InterMune-suing&nbsp;the agency to stop it from releasing what they called "commercially confidential information."

Those arguments evidently held enough weight with the General Court of the EU to merit an&nbsp;interim order&nbsp;barring the agency from publishing its transparency plan, at least for the time being.

Public Comment

In the meantime, EMA has been moving forward with plans to allow select access to the contested documents on a "case-by-case" basis, and has continued to discuss and debate the issue with industry and the public, including holding public workshops and soliciting comments from the public.

While the public consultation period ended on 1 October 2013, regulators are only now confirming what many industry watchers have long suspected: There is a huge amount of interest in this topic.

EMA said it had received more than 1,000 comments during its consultation period, a response it called "unprecedented."

"Patients, healthcare professionals, pharmaceutical industry representatives, researchers, transparency campaigners, academic and public institutions, health technology assessment bodies and a range of others sent their comments to the Agency," EMA wrote. "Many of the contributors provided detailed in-depth comments, some of them substantial, some of them technical, including suggestions relating to methodological and technical aspects of the implementation of the policy."

The large number of comments may be attributable in part to the AllTrials campaign, which has been organizing letter-writing campaigns and called on the public to weigh in on EMA's proposal.

EMA, for its part, said it was "grateful for this exceptional contribution from its stakeholders," and is now in the process of analyzing those comments-a process which will likely delay the final publication of the transparency policy.

An update will be forthcoming after the 11-12 December 2013 meeting of EMA's board, regulators said.